Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2019-5193

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2454711

Nom du titulaire (nom légal complet, aucune abbréviation): Bayer CropScience Inc.

Adresse: 160 QUARRY PARK BLVD. SE Suite 200

Ville: CALGARY

État: AB

Pays: Canada

Code postal /Zip: T2C 3G3

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez un animal domestique

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

04-JUN-19

5. Lieu de l'incident.

Pays: UNITED STATES

État: NORTH CAROLINA

6. Date de la première observation de l'incident.

Inconnu

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

Matière(s) active(s)

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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 432-1363

Nom du produit: Tempo SC Ultra

• Matière active
  • BETA-CYFLUTHRIN

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7. b) Type de formulation.

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Oui

9. Dose d'application.

Inconnu

10. Site d'application (choisir tout ce qui s'applique).

Site: Res. - In Home / Rés. - à l'int. maison

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Oui

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Shih Tzu

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

6. Âge (fournir un ordre de grandeur si nécessaire)

11

7. Poids (fournir un ordre de grandeur si nécessaire)

10.00

lbs

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Sang
  • Symptôme - Hypoglycémie
  • Symptôme - Leucoytose

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Oui

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Shih Tzu

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

10

7. Poids (fournir un ordre de grandeur si nécessaire)

10.00

lbs

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Système cardiovasculaire
  • Symptôme - Autre
  • Specify - Cardiac hypertrophy

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Inconnu

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Shih Tzu

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

8

7. Poids (fournir un ordre de grandeur si nécessaire)

10.00

lbs

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort

• Système respiratoire
  • Symptôme - Respiration faible

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Inconnu

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.

---

À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Shih Tzu

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

15

7. Poids (fournir un ordre de grandeur si nécessaire)

10.00

lbs

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Douleur

• Systèmes nerveux et musculaire
  • Symptôme - Faiblesse musculaire

12. Quelle a été la durée des symptômes?

Unknown / Inconnu

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Inconnu

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Euthanised / Euthanasie

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.

---

À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Shih Tzu

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

6. Âge (fournir un ordre de grandeur si nécessaire)

16

7. Poids (fournir un ordre de grandeur si nécessaire)

10.00

lbs

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Inconnu

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.

---

À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.